Multimodal exercise to support chemotherapy for newly diagnosed pediatric and AYA sarcoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants are newly diagnosed sarcoma patients aged 12–39 who are starting first-line systemic therapy and are medically cleared for activity. Enrollees will be assigned to a multimodal exercise intervention or usual care, with exit interviews to capture participant experience. The exercise program combines aerobic and resistance components tailored to each participant and is delivered during the period of chemotherapy initiation and early treatment. The primary outcome is chemotherapy uptake, measured as ability to start and continue planned systemic therapy without dose reductions or prolonged delays.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of Sarcoma
2. Pediatric or AYA (12-39 years old)
3. Able to provide written informed consent
4. Able to speak, read, and understand English or Spanish
5. Initiating first-line systemic therapy (Doxorubicin, Ifosfamide, Gemcitabine, Docetaxel, Trabectedin, Vincristine, Irinotecan, Temozolomide, Topotecan, Etoposide, Dacarbazine, Pazopanib, Tazemetostat, Imatinib, Sunitinib, Pembrolizumab, Nivolumab, Ipilumumab, Regorafenib, Atezulimumab). Participants can be enrolled up to 90 days after starting firstline systemic therapy.
6. Approval from a medical oncology provider to participate.
7. Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months
8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months

Exclusion Criteria:

1. \< 12 or \>39 years old
2. Unable to provide consent
3. Unable to read or understand English or Spanish
4. Oxygen-dependent
5. Unable to walk 2 blocks without assistance (excluding canes)
6. Unstable bone metastases
7. More than 90 days from initiation of first-line systemic therapy.
8. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention, as determined by the patient's provider and study clinician.

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Tracy E Crane, PhD, RDN — University of Miami
• Study coordinator: Grey Freylersythe, BS
• Email: g.freylersythe@med.miami.edu
• Phone: 305-243-9832

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.